Early failure of superior capsule reconstruction with human dermal allograft (Epiflex) in patients with massive rotator cuff tears: a clinical and radiological analysis.

Abstract

Massive rotator cuff tears (MRCT) are one of the major challenges in reconstructive shoulder surgery and the therapeutic concepts are still controversial. Using conventional reconstruction techniques rotator cuff re-tear rates still occur up to 52%-94% according to the recent literature. Therefore, superior capsule reconstruction (SCR) using acellular human dermal allografts (AHDG) are currently a frequently applied alternative treatment option for MRCT. Although the functional outcome improves, there is some discrepancy in survival time of the graft. The purpose of this study was to evaluate the structural graft integrity by magnetic resonance imaging (MRI) scans and the functional status of the shoulder early after surgery. Twenty-nine patients with conventionally irreparable MRCT were treated with an arthroscopic SCR utilized an AHDG (Epiflex, DIZG). Pre- and postoperative MRIs were used to evaluate the rotator cuff and graft configuration. The mean MRI follow-up was 9.8 ± 3.9 (6-21) weeks. The functional status was recorded regarding the Constant Score (CS) and active range of motion. General complications were noted. The clinical follow-up (FU) was 9.4 ± 2.9 (6-17) weeks and 1 year postoperatively at 42.5 ± 5.7 (36-58) weeks. The presence of a total graft failure rate of 59% type 3 according to Mirzayan after SCR with AHDG did not negatively influence the functional outcome during the observation period. There was the main effect of time on all directions of range of motion and all categories of the CS-Score (pain: P < .001, activity: P = .01 and motion: P = .04) except for CS-force value (P = .28) at the first FU and the improvement remained constant until the last FU. There were no significant differences in clinical outcome between the group with graft failure and the group with intact graft at the first and last FU. The SCR with AHDG in MRCT shows high rate of structural graft failures in early postoperative MRI. However, this does not correlate with the functional outcome in early and mid-term FU. Further studies focusing to elucidate the underlying complex process of in vivo AHDG regeneration and recent developments of biological graft healing and surgery techniques may improve the structural integrity of the SCR construct.